GDUFA Research Outcomes

PBPK Models

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to physiologically-based pharmacokinetics (PBPK) computational modeling to support generic product development and assessment.

• All(430)
• Posters(94)
• Presentations(218)
• Papers(118)

• Physiologically-based Pharmacokinetic Model to Support Ophthalmic Suspension Product Development

  Le Merdy, Maxime; Fan, Jianghong; Babiskin, Andrew; Zhao, Liang

• Clinical Ocular Exposure Extrapolation Using PBPK Modeling and Simulation: Levofloxacin Solution Case Study

  Le Merdy, Maxime; Zheng, Yujuan; Lukacova, Viera; Tan, Ming Liang; Babiskin, Andrew; Zhao, Liang

• Physiologically-based Pharmacokinetic Model to Support Ophthalmic Suspension Product Development

  LeMerdy, Maxime; Fan, Jianghong; Babiskin, Andrew; Zhao, Liang

• Application of Ocular Physiologically Based Pharmacokinetic Modeling to Understand the Impact of Particle Size and Viscosity on Ophthalmic Bioavailability of Tobradex ST Suspension in Rabbits

  Lemerdy, Maxime; Tsakalozou, Eleftheria; Choi, Stephanie; Kim, Myongjin; Xu, Lin; Stewart, Sharron; Chockalingam, Ashok; Rouse, Rodney; Matta, Murali; Zhao, Liang; Lionberger, Robert; Fan, Jianghong

• Clinical Ocular Exposure Extrapolation Using PBPK Modeling and Simulation: Moxifloxacin Solution Case Study

  Le Merdy, Maxime; Lukacova, Viera; Tan, Ming-Liang; Babiskin, Andrew; Zhao, Liang

• Impact of Changes in Ophthalmic Emulsion Globule Size Distribution and Viscosity on Tear Film Thickness and Menisci Characteristics

  Kumar, Sandeep; Cook, Nicholas; Gum, Glenwood; Manza, Linda; Naageshwaran, Vatsala; Lyulkin, Mathew; Xu, Xiaoming; Patel, Deval; Qu, Haiou; Walenga, Ross; Tan, Ming Liang; Babiskin, Andrew; Kaisar, Mohmmad Abul

• On the Importance of Liquid Motion in Nasal Spray Delivery

  Kolanjiyil, A; Golshahi, L; Longest, W

• How Spray Metric Variability Impacts the Initial Deposition of Nasal Sprays

  Kolanjiyil, Arun; Hosseini, Sana; Alfaifi, Ali; Golshahi, Laleh; Hindle, Michael; Longest, Worth

• Effect of Spray Momentum on Nasal Spray Droplet Transport and Deposition

  Kolanjiyil, Arun; Hosseini, Sana; Manniello, Michele; Alfaifi, Ali; Farkas, Dale; Golshahi, Laleh; Longest, Worth

• The Effect of PLGA Molecular Weight on Drug Release from Microspheres

  Kohno, Moe; Andhariya, Janki; Rothstein, Sam; Wang, Yan; Qin, Bin; Burgess, Diane